Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Appendix D: Clinical evidence tables - 1 - 4731 Study APEX trial: Wylde 2015236 - 3722 Study type RCT (Patient randomised; Parallel) - 6 Number of studies (number of participants) 1 (n=322) Countries and setting Conducted in United Kingdom; Setting: UK elective orthopaedic centre Line of therapy Not applicable1 73 Duration of study Intervention + follow up: Surgery and 12 months follow-up Method of assessment of guideline Adequate method of assessment/diagnosis condition Stratum Overall Subgroup analysis within study Not applicable Inclusion criteria Primary unilateral THR for osteoarthritis Exclusion criteria Medical comorbidity that precluded spinal anaesthesia, regional blocks, or strong analgesics postoperatively because inability to tolerate these pain relief strategies may have influenced the trial results; severe dementia or psychiatric illness; listing for simultaneous bilateral joint replacement; previous participation in the trial; inability to understand English. 1 If an anaesthetic doesn’t appear to be working then often the anaesthetist will supplement this with analgesics Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Recruitment/selection of patients People were recruited at the preoperative assessment clinic by a research nurse and randomized before surgery by the trial administrator. - 1 - Age, gender and ethnicity Age - Mean (SD): 66 (11) and 66 (10). Gender (M:F): 133/189. Ethnicity: Not detailed 4731 - Further population details 1. Age: Not stated / Unclear 2. ASA grade: Not stated / Unclear 3722 - Indirectness of population No indirectness 6 Interventions (n=163) Intervention 1: Regional - Regional anaesthesia with local infiltration analgesia (during or after surgery). Spinal anaesthetic using bupivacaine. Intraoperative local anaesthetic infiltration using bupivacaine with adrenaline. The local anaesthetic mixture was injected into the joint capsule and short external rotators, fascia, fat, and subcutaneous tissue before closure of the wound.. Duration Surgery. Concurrent medication/care: Intraoperatively, the patient was awake, sedated, or under light general anaesthetic depending on patient and anaesthetic factors. Indirectness: No indirectness 74 (n=159) Intervention 2: Regional - Regional anaesthesia. Spinal anaesthetic using bupivacaine.. Duration Surgery. Concurrent medication/care: Intraoperatively, the patient was awake, sedated, or under light general anaesthetic depending on patient and anaesthetic factors. Indirectness: No indirectness Funding Research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-0407-10070) RESULTS (NUMBERS ANALYSED) AND RISK OF BIAS FOR COMPARISON: REGIONAL ANAESTHESIA WITH LOCAL INFILTRATION ANALGESIA (DURING OR AFTER SURGERY) versus REGIONAL ANAESTHESIA Protocol outcome 1: Postoperative pain at within 30 days - Actual outcome: No pain on admission to recovery ward at .; Group 1: 115/163, Group 2: 111/159 Risk of bias: All domain - Low, Selection - Low, Blinding - Low, Incomplete outcome data - Low, Outcome reporting - Low, Measurement - Low, Crossover - Low, Subgroups - Low; Indirectness of outcome: No indirectness ; Group 1 Number missing: ; Group 2 Number missing: Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Protocol outcome 2: Nausea at within 30 days - Actual outcome: Nausea and vomiting at During recovery from surgery; Group 1: 80/153, Group 2: 88/155 Risk of bias: All domain - Low, Selection - Low, Blinding - Low, Incomplete outcome data - Low, Outcome reporting - Low, Measurement - Low, Crossover - - Low, Subgroups - Low; Indirectness of outcome: No indirectness ; Group 1 Number missing: 10; Group 2 Number missing: 5 1 - 4731 Protocol outcomes not reported by the Mortality at within 90 days; Quality of life at within 30 days; Postoperative neurocognitive decline at within - 3722 study 30 days; Thromboembolic complications at within 90 days; Hospital readmissions at within 30 days days; Postoperative use of analgesia at as reported; Length of stay at .; Mobilisation within 24 hours after surgery - 6 at . 75 Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Study Basques 201518 Study type Non-randomised comparative study - 1 - 4731 Number of studies (number of participants) 1 (n=20936) - 3722 Countries and setting Conducted in USA; Setting: - 6 Line of therapy Not applicable Duration of study --: Method of assessment of guideline Adequate method of assessment/diagnosis condition 76 Stratum Overall Subgroup analysis within study Not applicable Inclusion criteria People undergoing primary elective total hip arthroplasty for osteoarthritis of the hip Exclusion criteria None detailed Recruitment/selection of patients American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2010 to 2012. Age, gender and ethnicity Age - Other: 16% under 55, 30% 55-64, 31% 65-74, 24% 75 plus.. Gender (M:F): Define. Ethnicity: Not detailed Further population details 1. Age: Mixed 2. ASA grade: Mixed Indirectness of population No indirectness Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Interventions (n=12752) Intervention 1: General - General anaesthesia. General anaethesia. Duration Surgery. Concurrent medication/care: Not detailed. Indirectness: No indirectness - 1 - (n=8184) Intervention 2: Regional - Regional anaesthesia. Spinal anaesthesia. Duration Surgery. Concurrent 4731 medication/care: Not detailed. Indirectness: No indirectness - 3722 Funding Funding not stated (Some conflicts of interest declared. One author in this study received a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health (Award - 6 Number TL1TR000141). Funds were used to pay for salary and equipment.) RESULTS (NUMBERS ANALYSED) AND RISK OF BIAS FOR COMPARISON: REGIONAL ANAESTHESIA versus GENERAL ANAESTHESIA Protocol outcome 1: Mortality at within 90 days - Actual outcome: Death at Within 30 days of surgery; OR; 1.19 (95%CI 0.57 to 2.53, Comments: Propensity-adjusted multivariate logistic regression. 77 Bivariate and propensity-adjusted multivariate regressions were used to compare the rates of adverse outcomes that occurred with general anesthesia and spinal anesthesia, using spinal anesthesia cases as the reference. Multivariate regression adjusted for baseline differences in patient demographic characteristics and comorbidities as well as the propensity score.); Risk of bias: All domain - Low, Selection - Low, Blinding - Low, Incomplete outcome data - Low, Outcome reporting - Low, Measurement - Low, Crossover - Low, Subgroups - Low; Indirectness of outcome: No indirectness ; Group 1 Number missing: ; Group 2 Number missing: Protocol outcomes not reported by the Quality of life at within 30 days; Postoperative pain at within 30 days; Postoperative neurocognitive decline study at within 30 days; Thromboembolic complications at within 90 days; Hospital readmissions at within 30 days days; Postoperative use of analgesia at as reported; Length of stay at .; Nausea at within 30 days days; Mobilisation within 24 hours after surgery at . Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Study Chen 201040 Study type RCT (Patient randomised; Parallel) - 1 - 4731 Number of studies (number of participants) 1 (n=92) - 3722 Countries and setting Conducted in Taiwan - 6 Line of therapy Not applicable Duration of study Intervention + follow up: Surgery and 12 weeks follow up Method of assessment of guideline Adequate method of assessment/diagnosis condition 78 Stratum Overall Subgroup analysis within study Not applicable Inclusion criteria People with osteoarthritis or osteonecrosis, aged 18 to 80 years old, undergoing unilateral THA Exclusion criteria Consent not given or unable to be given, neuropathic pain or sensory disorders in the leg, previous surgery of the hip, coagulation abnormalities, severe renal or hepatic impairment, chronic opioid users, known history of intolerance to study drugs. Recruitment/selection of patients August 2007 to March 2008 Age, gender and ethnicity Age - Mean (SD): 52 (13) and 54 (14). Gender (M:F): 54/37. Ethnicity: Not detailed Further population details 1. Age: Mixed 2. ASA grade: Mixed Extra comments . Administration of anti-inflammatory drugs suspended a week before. Anaesthesia for elective hipreplacement joint Final Joint replacement: ISBN 978 ISBN Indirectness of population No indirectness Interventions (n=46) Intervention 1: General - General anaesthesia with local infiltration analgesia (during or after - 1 - procedure). General anaesthesia with propofol and fentanyl. After closing of capsule people received 4731 subcutaneous injection of 12ml 0.5% bupivicaine. Then 2ml/h 0.5% bupivicaine for 48 hours. Duration - Surgery with 12 weeks follow up. Concurrent medication/care: Surgery was standardised technique through 3722 anterolateral approach. Indirectness: No indirectness - 6 (n=46) Intervention 2: General - General anaesthesia. General anaesthesia with propofol and fentanyl. After closing of capsule people received subcutaneous injection of 12ml saline. Then 2ml/h saline for 48 hours. Duration Surgery with 12 weeks follow up. Concurrent medication/care: Surgery was standardised technique through anterolateral approach. Indirectness: No